Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants (i-CBT)

December 5, 2025 updated by: Shervin Shahnavaz, Karolinska Institutet

Culturally and Language-Adapted i-CBT for Common Mental Health Problems: A Randomized Controlled Study With Farsi/Dari-Speaking Migrants

The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants who are included in the study will be allocated to the experimental group and the control group (waiting list). Participants will be invited to participate tailored i-CBT intervention over 10-weeks. Intervention covers common psychological issues. Participants will have access to support through a chatting function, during the interventional period. Intervention effects will be measured prior-treatment, post-treatment, and 6 months post-treatment.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 15 and 29.
  • A score above the cut-off 1.75 on HSCL-25
  • Has a refugee or migrant background
  • Has a good and stable internet connection
  • Has access to a computer, tablet or smartphone
  • Is fluent in reading and writing Arabic
  • Has the ability to dedicate time to take part in the intervention for 6-10 weeks.

Exclusion Criteria:

  • Is suffering from a severe mental illness, such as psychosis or severe depression.
  • Is suffering from substance abuse
  • Is undergoing a psychological treatment
  • Has a high risk of suicide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active group
Tailored I-CBT for mild to moderate common mental health problems over a 10-weeks-period.
Behavioral: Culturally adapted i-CBT
A culturally and language adapted i-CBT intervention for Farsi/Dari speaking youth migrants and refugees. The intervention targets mild to moderate common mental health problems.
No Intervention: Waiting-list
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hopkins Symptom Checklist-25 (HSCL-25)
Time Frame: Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention
Assessment of anxiety and depressive symptoms. HSCL-25 consists of 25 items.Each item is rated on a scale from 1 to 4, where 1 means "Not at all" and 4 means "Extremely".Higher scores indicate a worse outcome, as they reflect greater severity of symptoms.
Pre-intervention, up to 5 weeks, immediately after the intervention, 6 months after completion of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Outcome Profiles (PSYCHLOPS)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Impact of problematic area on function. PSYCHLOPS questionnaire consists of 4 items. These items are designed to capture the patient's main problem, the impact of this problem on their daily life, and their overall well-being. Each question in PSYCHLOPS is scored on a scale from 0 to 5, where 0 indicates no problem and 5 indicates the most severe problem. Higher scores indicate a worse outcome, as they reflect greater severity of problems or distress.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Insomnia Severity Index (ISI)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of severity of insomnia symptoms. ISI consists of 7 items, each rated on a scale from 0 to 4.Higher scores indicate a worse outcome, as they reflect more severe insomnia symptoms.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Prolonged Grief Disorder (PG-13)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of prolonged grief disorder. The PG-13 consists of 13 items, each rated on a scale from 1 to 5, where 1 means "Not at all" and 5 means "Several times a day". Higher scores indicate a worse outcome, as they reflect more severe symptoms of prolonged grief.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Posttraumatic Stress Disorder Checklist (PCL-5)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of symptoms of post-traumatic stress disorder. The PCL-5 consists of 20 items, each rated on a scale from 0 to 4. The total score ranges from 0 to 80. Higher scores indicate a worse outcome, as they reflect greater severity of PTSD symptoms.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
The World Health Organization-Five Well-Being Index (WHO-5)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of subjective psychological well-being.The WHO-5 consists of 5 items, each rated on a scale from 0 to 5. Higher scores indicate a better outcome, as they reflect higher levels of well-being.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Brief Resilience Scale (BRS)
Time Frame: Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Assessment of resilience.The BRS consists of 6 items, each rated on a scale from 1 to 5. Higher scores indicate a better outcome, as they reflect greater resilience.
Pre-intervention, immediately after the intervention, 6 months after completion of the intervention
Client Satisfaction Questionnaire (CSQ-3)
Time Frame: Immediately after the intervention, 6 months after completion of the intervention
Assessment of the levels of satisfaction of the participant with the intervention.CSQ-3 consists of 3 items. Each item is rated on a scale from 1 to 4. Higher scores indicate a better outcome, as they reflect greater satisfaction with the services received.
Immediately after the intervention, 6 months after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Gerhard Andersson, PhD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI-CNS-20250117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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